Reimb of PE exemption drugs can be ex officio rejected

if they do not satisfy the required conditions

HIRA announces the revision of detailed evaluation standards for new drugs subject to negotiation such as new drugs, etc.

Review for drugs that sign over 3 refund-type RSA contracts will be simplified and briefly reviewed mainly for changes

In the future, drugs that sign refund-type risk-sharing agreements will be reviewed briefly by the Health Insurance Review and Assessment Service, focusing on changes, when a drug is reimbursed through the signing of the risk-sharing agreement more than 3 times.

 

In addition, if a drug applies as a drug that can skip submission of pharmacoeconomic evaluation data but does not meet the requirements, such application can be rejected without committee deliberation.

 

HIRA released a revision to the 'Detailed Evaluation Criteria for New Drugs and Other Drugs Subject to Negotiation' on the 12th that contains the changes above.

 

The revision, which was finalized after deliberations by the Drug Reimbursement Evaluation Committee on the 5th, reflects improvements to the system for rewarding the innovation value of new drugs reported to the Health Insurance Policy Review Committee last year.

 

HIRA has already revised the criteria once to reward the new drugs’ innovative value once in August.

 

The new revision contains simplification of review for drugs that have signed 3 or more risk-sharing contracts.

 

Specifically, it is possible to briefly review refund-type drugs, excluding multiple RSA-type drugs, starting from the evaluation related to the expiration of the second risk-sharing contract period (in the case the drug is signing the third or further risk-sharing contract), focusing on changes.

 

There are also new requirements set to reject applications for ineligible PE exemption drugs.

 

If an applicant applies for a determination that a drug falls under Article 6 (Drugs deemed essential for medical treatment) or Article 6.2 (Drugs that can waive the submission of pharmacoeconomic evaluation data) of the Regulations on Evaluation Criteria and Procedures for Eligibility for Medical Treatment Benefits, etc.’ HIRA stated that this addition was made to “clarify the processing criteria for drugs that are waived submitting pharmacoeconomic evaluation data for but fail to submit required data to improve work efficiency.”